NAD Augmentation to Treat Diabetes Kidney Disease: A Randomized Controlled Trial
A phase 2a trial randomized, double-blind, placebo-controlled, parallel group trial to determine whether NMN administration improves DKD, as indicated by a significantly greater reduction in UACR compared with placebo administration. Eligible participants will be randomized to receive either 1000 mg NMN or placebo twice daily.
• A man or a postmenopausal woman (complete cessation of menses for one or more years and /or FSH \> 20 U/L), 30 years or older
• Has type 1 or type 2 diabetes mellitus, as indicated by any of the following:
‣ Self-report of type 1 or type 2 diabetes plus the use of a prescribed medication.
⁃ ICD-10 code for type 1 or type 2 diabetes plus current use of a medication in the electronic medical record.
⁃ HbA1c \>6.4%; or 2 fasting glucose \> 125 mg/dL
• Has an average of two or more morning UACR equal to or above 100mg/g creatinine each of which must be equal to or greater than 60 mg / g creatinine with at least one UACR value measured during the screening visit.
• a. Recent UACR value in the medical record within the preceding 3 months prior to screening is acceptable.
• If type 2 diabetic and UACR is \> 300 mg/g creatinine, must be currently using an ACE inhibitor or an ARB or a SGLT2 inhibitor.
• eGFR \> 25 mL/ min / 1.73 m2
• Hemoglobin A1c \<10%
• Able to speak English or Spanish or Haitian Creole
• Willing and able to provide written informed consent
• In addition, female participants must Not be pregnant and not planning to become pregnant over the next 6 months.